Multi-chamber bag for the production of dialysate

Abstract

The present invention relates to a multi-chamber bag for producing a medical solution, in particular a dialysate. The multi-chamber bag has at least two chambers that are linked to each other via a peel seam and each chamber is delimited by a respective sealing seam at a first side and a second side opposite the first side, and the multi-chamber bag has a third side formed by a folded-over film, at least one port being formed at the third side by way of butt welding.

Description

[0001] Multi-chamber bag for the preparation of dialysate

[0002] The present invention relates to a multi-chamber bag for producing dialysate and a method for producing such a multi-chamber bag.

[0003] Dialysis often involves using bags containing pre-prepared dialysate or at least partial components. For example, for storage stability reasons, it may be advantageous to store partial components of a solution, such as dialysate, separately and only mix them immediately before use.

[0004] Multi-chamber bags are often used for this purpose, which contain separate subcomponents in separate chambers, which are mixed together immediately before use of a produced solution.

[0005] For example, such multi-chamber bags can contain two different solutions, a solution and a dry concentrate, a solution and a paste-like concentrate, or any other contents. Examples include solutions for peritoneal dialysis or hemofiltration, as well as preparations for parenteral nutrition.

[0006] EP 0 935 967 discloses a solution for peritoneal dialysis consisting of two individual solutions provided in a two-chamber bag. The first individual solution comprises calcium ions, other electrolyte salts, and glucose in an osmotically effective concentration. The second individual solution comprises bicarbonate and the salt of a weak acid with pKa (5). Both chambers must be mixed before use to obtain the ready-to-use peritoneal dialysis solution.

[0007] WO 2003 / 059417 discloses a two-part dialysis solution comprising a first component comprising a bicarbonate concentrate, a second component comprising an electrolyte concentrate, which is provided in a two-chamber bag and is mixed immediately before use.

[0008] Conventional multi-chamber bags have a connection or filling port for filling each chamber. The required connectors, filling nozzles, and closure caps complicate the production and use of such multi-chamber bags.

[0009] Against this background, the present invention is based on the object of mitigating or even completely eliminating the problems of the prior art. In particular, the present invention is based on the object of creating a simplified and more cost-effective multi-chamber bag and an associated manufacturing method.

[0010] This object is achieved by a multi-chamber bag having the features of claim 1 and a method having the features of claim 9.

[0011] Further advantageous modifications of the invention are the subject of the subclaims.

[0012] Accordingly, a multi-chamber bag for producing a medical solution, in particular dialysate, is provided, comprising at least two chambers connected to one another via a peel seam and each of which is bounded by a sealing seam on a first and a second opposite side of the bag. The multi-chamber bag further comprises a third side formed by a folded-over film, on which at least one connection is arranged by butt welding.

[0013] Attaching the connector to the third side preferably offers the advantage that the connector sits on an outermost layer of the folded film and is not integrated into the folded film or its layer structure or sandwiched between two films.

[0014] The term "butt welding" preferably refers to a process in which two end faces are butt-welded together. Butt welding is also known as mirror welding.

[0015] For example, the connection comprises a hose section. First, one end of the hose section is widened, preferably in a tulip shape, to create a larger end face similar to a flange. The end face of the hose section is then placed on a surface, such as a film, and welded to it.

[0016] In this procedure, the end face of the tube section then sits on the surface of the film and is not integrated into it, for example in the case of a multi-layer film, it is arranged between the layers of the multi-layer film or sandwiched between two films.

[0017] Butt welding allows for particularly strong and resilient connections. A plurality of connections can be arranged on the third side, at least one of which, preferably all of which, are attached to the film by butt welding.

[0018] According to one embodiment, the multi-chamber bag has a sealed seam on a fourth side opposite the third side, preferably with one or more hanging loops. The sealed seam preferably has a width such that the hanging loop(s) are completely enclosed by the sealed seam.

[0019] Preferably, the multi-chamber bag, but at least one chamber of the multi-chamber bag, does not have a filling port for filling at least one chamber of the multi-chamber bag, preferably in the form of a connection, port or connector.

[0020] Such a filling port is preferably understood to mean an access to a receiving area of ​​the bag, which is designed to fill the receiving area of ​​the bag before delivery of the bag or bag system to an end user or before use of the bag in peritoneal dialysis. After filling, the filling port is usually permanently sealed, for example with a cap.

[0021] Such a filling port is preferably not required, since a multi-chamber bag according to the invention is preferably filled using a method according to the invention before the bag is closed.

[0022] Thus, it is not necessary to direct a liquid, for example, into a chamber of the bag via a port; instead, the chamber is only closed and formed after it has been filled. It is conceivable for the multi-chamber bag to have only one connection for removing contents from the bag, with at least one chamber of the multi-chamber bag preferably not having its own connection, port, or connector. The contents of this chamber can preferably only escape to the outside via the connection of another chamber of the multi-chamber bag, for example, after a peel seam separating the chambers has been opened.

[0023] According to one embodiment, the multi-chamber bag has a first chamber and a second chamber, wherein the first chamber is delimited by the third side having the connection and the second chamber can be connected to the first chamber by opening the peel seam, so that a content of the second chamber can only be brought out via the first chamber and the connection on the third side of the bag.

[0024] The second chamber is preferably limited exclusively by the peel seam, the sealing seams on the first and second sides and the sealing seam on the fourth side.

[0025] Preferably, a longitudinal axis of the peel seam extends at right angles or substantially at right angles to a longitudinal axis of the multi-chamber bag. This allows two chambers of different sizes to be easily formed.

[0026] Alternatively, the peel seam can also extend parallel to a longitudinal axis of the multi-chamber bag.

[0027] According to one embodiment, the at least two chambers of the bag each have a content designed to produce ready-to-use dialysate when combined with the contents of the other chamber of the multi-chamber bag. For example, at least one chamber can contain an acidic concentrate and the other chamber an ionic solution. At least one chamber can contain bicarbonate and / or an osmotic agent, for example, a saponin.

[0028] Furthermore, the present invention relates to a method for producing a multi-chamber bag, preferably a multi-chamber bag according to the invention, comprising the steps: a) providing a flat film with two outer edges;wherein the flat film can be a multi-layer or single-layer film, b) fixing at least one connection to the flat film by butt welding, and preferably creating an opening in the flat film in the region of the connection, for example by punching or by means of a hot mandrel, c) creating a film tube from the flat film, preferably by means of a forming shoulder over which the flat film runs, and sealing the outer edges of the flat film to one another, d) creating a peel seam between two layers of the flat film of the film tube, which peel seam releasably connects the two layers of the flat film to one another, runs between two outer edges of the film tube along a longitudinal direction of the film tube, thereby creating at least two receiving areas separated from one another by means of the peel seam;e) creating a sealing seam running at right angles or substantially at right angles to the peel seam, whereby a receiving pocket is created in each of the two receiving areas, f) filling the two receiving pockets along the longitudinal direction of the film tube, preferably with two different contents; and g) closing the two receiving pockets by creating a further sealing seam running at right angles or substantially at right angles to the peel seam, whereby the receiving pockets are closed and at least two completely closed chambers are formed.

[0029] During butt welding in step b), the following parameters are preferably used:

[0030] Welding temperature: 150°C < T < 300°C

[0031] Welding time: 0.7 s < t < 2 s

[0032] Welding pressure: 0.1 N / mm 2 < a < 2 N / mm 2

[0033] The following parameters are particularly preferred:

[0034] Welding temperature: 190°C < T < 250°C

[0035] Welding time: 0.9 s < t < 1 .5 s

[0036] Welding pressure: 3000N at A=6300mm 2 — ► 0.48 N / mm 2

[0037] Preferably, multi-chamber bags are produced continuously along a continuous film tube, each of which is connected to one another via a sealing seam, and which are each separated from one another by cutting along a sealing seam running at right angles or substantially at right angles to the peel seam.

[0038] In other words, a continuous film tube is preferably produced, which is filled in the longitudinal direction of the tube and which is portioned into different bags by sealing in the transverse direction.

[0039] Thus, when filling the tube, two columns of filling material are preferably formed, parallel to each other and separated by the peel seam. These columns are divided into several multi-chamber bags by transverse sealing. According to one embodiment, in step f), the at least two receiving pockets are filled by two separate filling lances with a liquid, solid, and / or pasty content, which is preferably designed for the production of dialysate.

[0040] Preferably, a multi-chamber bag according to the invention and its butt-welded connection are made of a polymer material and are designed as a single-use article or disposable.

[0041] Preferably, a method according to the invention is carried out with a single machine.

[0042] At this point, it should be noted that the present disclosure is not limited to the explicitly mentioned combinations of features, but the features disclosed herein may also be claimed in other combinations or in isolation.

[0043] Further advantages, effects and features of the present invention will become apparent from the following description of preferred embodiments with reference to the drawings, in which like reference numerals designate like or similar components.

[0044] This shows:

[0045] Fig. 1 shows a multi-chamber bag according to the invention, and

[0046] Fig. 2 shows a continuous production of multi-chamber bags according to the invention from a continuous film tube.

[0047] Fig. 1 shows a multi-chamber bag 1 according to the invention with two chambers A and B, which are connected to one another via a peel seam 2 and which are each delimited on a first and a second opposite side 3 and 4 by a sealing seam.

[0048] The multi-chamber bag 1 further comprises a third side 5 formed by a folded film, on which two connections in the form of hose sections 6 are arranged by butt welding.

[0049] The bag 1 is produced from a flat film by folding the film at the third side 5 and sealing the outer edges of the flat film together at a fourth side to form a sealed seam 7, initially creating a film tube. At least one hanging eyelet 8 is attached to the sealed seam 7, which is located opposite the connections 6.

[0050] The transverse sealing seam shown in Fig. 1 at the lower end (second side 4) of the bag 1 is then created.

[0051] In this intermediate state, the chambers A and B are still open on their upper side in Fig. 1 and thus form receiving pockets which can be conveniently filled from above (in the view shown in Fig. 1).

[0052] After filling the receiving pockets, the transverse sealing seam shown in Fig. 1 at the upper end (first side 3) of the bag 1 is created, whereby the receiving pockets are closed and the chambers A and B are formed.

[0053] Chamber B does not have its own connection or port, so the contents of Chamber B can only escape to the outside via the opened peel seam 2, Chamber A and its connections.

[0054] Fig. 2 shows a continuous production of multi-chamber bags 1 according to the invention from a continuous film tube 9. As shown in Fig. 2, a film tube 9 preferably extends vertically during filling. In the view shown in Fig. 2, the film tube 9 comprises four multi-chamber bags 1, which are not yet separated from one another in this view, but are each connected to one another by a common transverse seal on the sides 3, 4.

[0055] The common transverse sealing seam on the sides 3, 4 separates the chambers A and B of adjacent multi-chamber bags 1. Each bag 1 is equipped with a butt-welded connection 6.

[0056] The uppermost bag shown in Fig.2 illustrates the filling of chambers A and B. In this bag, chambers A and B are not yet closed at their upper end shown in Fig. 2 and therefore form receiving pockets TA and TB for the filling material.

[0057] Each receiving pocket TA, TB is filled with a specific content using a dedicated filling device, e.g., a filling lance 10, 11, preferably from above in a vertical direction. Once the receiving pockets TA and TB are sufficiently filled, they are sealed by transverse sealing.

[0058] This type of filling eliminates the need to equip chambers A and B of the multi-chamber bag with a filling connection or port.

[0059] In order to separate the individual bags 1 of the continuous film tube 9 from one another, they are cut apart in the transverse direction along the common transverse sealing seam on the sides 3,4.

Claims

Claims 1. Multi-chamber bag for producing a medical solution, in particular dialysate, with at least two chambers which are connected to one another via a peel seam and which are each delimited on a first and a second opposite side by a respective sealing seam, characterized in that the multi-chamber bag further has a third side formed by a folded-over film, on which at least one connection is arranged by means of butt welding.

2. Multi-chamber bag according to claim 1, characterized in that the multi-chamber bag has a sealing seam with preferably a hanging eyelet on a fourth side opposite the third side.

3. Multi-chamber bag according to claim 1 or 2, characterized in that the multi-chamber bag does not have a filling port for filling at least one chamber of the multi-chamber bag, preferably in the form of a connection, port or connector.

4. Multi-chamber bag according to one of the preceding claims, characterized in that the multi-chamber bag has a first chamber and a second chamber, wherein the first chamber is at least partially delimited by the third side having the connection and the second chamber can be connected to the first chamber by opening the peel seam, so that a content of the second chamber can only be brought to the outside via the first chamber and the connection on the third side.

5. Multi-chamber bag according to claim 4, characterized in that the second chamber is limited exclusively by the peel seam, the sealing seams on the first and second sides and the sealing seam on the fourth side.

6. Multi-chamber bag according to one of the preceding claims, characterized in that a longitudinal axis of the peel seam extends at right angles or substantially at right angles to a longitudinal axis of the multi-chamber bag.

7. Multi-chamber bag according to one of the preceding claims, characterized in that the at least two chambers of the bag each have a content which is designed to produce ready-to-use dialysate when the content is combined with a content of the other chamber of the multi-chamber bag.

8. Multi-chamber bag according to one of the preceding claims, characterized in that the connection on the third side is welded in such a way that it sits on an outermost layer of the folded film and is not arranged between two films or integrated into the folded film or its layer structure. A method for producing a multi-chamber bag, preferably a multi-chamber bag according to one of claims 1 to 8, comprising the steps: a) providing a flat film with two outer edges; b) fixing at least one connection to the compartment film by butt welding, c) producing a film tube from the flat film by sealing the outer edges of the flat film to one another, d) producing a peel seam which runs between two outer edges of the film tube along a longitudinal direction of the film tube, thereby creating at least two receiving areas separated from one another by the peel seam; e) producing a sealing seam running at right angles or substantially at right angles to the peel seam, thereby creating a receiving pocket in each of the two receiving areas, f) filling the two receiving pockets along the longitudinal direction of the film tube, preferably with two different contents;and g) closing the two receiving pockets by creating a further sealing seam running at right angles or substantially at right angles to the peel seam, thereby closing the receiving pockets and forming at least two completely sealed chambers; 10. The method according to claim 9, characterized in that multi-chamber bags are produced continuously along a continuous film tube, each of which is connected to one another via a sealing seam, and which are each separated from one another by cutting along a sealing seam running at right angles or substantially at right angles to the peel seam.

11. Method according to claim 8 or 9, characterized in that in step f) the two receiving pockets are filled by two separate filling lances with a liquid, solid and / or pasty content which is designed for the production of dialysate.

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